Progressive Resistance and Flexibility Exercises Versus Usual Care Advice for Improving Pain and Function After Distal Radius Fracture in Adults Aged 50 Years or Over in Denmark: the WISE-DK Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 588
- 试验地点
- 1
- 主要终点
- Patient-Rated Wrist Evaluation (PRWE)
研究概览
简要总结
The goal of this clinical trial is to find out whether a therapist-guided exercise program helps people aged 50 and older recover better, in terms of pain and function, after a wrist fracture, compared to the usual care advice they would normally receive. The main question it aims to answer is:
• Will participants who receive a therapist-supervised exercise program have better improvement in pain and function, as measured by the Patient Rated Wrist Evaluation questionnaire, six months after their injury?
Researchers will compare these participants with those who receive usual care, which includes advice on self-management, to see if the supervised exercise program leads to greater recovery.
Participants will:
- Either receive supervised exercise, with a therapy session of up to 60 minutes and two additional sessions of up to 30 minutes each in addition to usual-care, or they will receive solely usual-care, consisting of advice on self-management.
- Complete questionnaires electronically at baseline, 3-months, and 6-months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statistical analysis
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Distal radius fracture treated surgically or non-surgically
- •Willing and able to give informed consent
排除标准
- •Injury is more than two months old
- •There is evidence that the patient would be unable to participate in therapy or a self-guided exercise program provided by a participating center or adhere to study procedures (including cognitive impairment and fracture/surgery complications such as Complex Regional Pain Syndrome)
- •No e-mail address to receive electronic questionnaires
- •Open fractures with a Gustilo & Anderson grading >1
研究组 & 干预措施
Supervised Exercise in addition to Usual Care (intervention)
干预措施: Supervised Exercise (Other)
Supervised Exercise in addition to Usual Care (intervention)
干预措施: Usual Care (Other)
Usual Care
干预措施: Usual Care (Other)
结局指标
主要结局
Patient-Rated Wrist Evaluation (PRWE)
时间窗: Measured at baseline, 3 months and 6 months follow-up
The primary outcome is the Patient Rated Wrist Evaluation (PRWE) at 6 months post-randomization: A 15 item patient-reported questionnaire that assesses pain and functional difficulties in activities of daily living resulting from injuries affecting wrist joint area (total score ranges from 0 to 100, higher scores indicate worse wrist pain and function). The pain subscale has 5 items (0 = no pain, 10 = worst pain) and the function subscale has 10 items (0 = no difficulty, 10 = unable to do). A total score on a scale of 100 is computed from the two subscales equally weighted (0 = no disability). The total score is the trial primary outcome, with the two subscales also reported as secondary outcomes.
次要结局
- Wrist pain subscale measured using the Patient Rated Wrist Evaluation (PRWE)(Baseline, 3 months and 6 months follow-up)
- Wrist function subscale measured using the Patient Rated Wrist Evaluation (PRWE)(Baseline, 3 months and 6 months follow-up)
- PROMIS Physical Function Upper Extremity-Short Form 7a(Baseline, 3 months and 6 months follow-up)
- QuickDASH(Baseline, 3 months and 6 months follow-up)
- EuroQol 5 Dimensions (EQ-5D-5L)(Baseline, 3 months and 6 months follow-up)
- Self-Efficacy for Exercise scale (SEE)(Baseline, 3 months and 6 months follow-up)
- Exercise adherence measured by self-reported exercise frequency(3 months and 6 months follow-up)
- Serious adverse events (SAEs)(3 months and 6 months follow-up)
- Adverse events (AEs)(3 months and 6 months follow-up)